+91-9619854045/47

info@pharmalinksindia.com
 
 

Our Strength



  • Technology Development Centre in India with focus on new APIs with non-infringing process development.
  • Technology transfer from Lab to Plant.
  • Highly qualified team for Process and Analytical Development,Experienced Regulatory and IPR Team.
  • Emphasis on QMS complying to ICH Q7A - GMP guidelines, 21 CFR Part 210-211 and WHO GMP.

Over the years we have partnered with some of the best names in the International Pharma Industry to provide our customers with consistent and customized service :-

Service



 

Core Effective Process

Our Capabilities for services in API & Formulation Business

  • Cost Effective Process Development & Manufacturing - APIs & Intermediates.
  • Documentation for Technology Transfer (TT).
  • Quality Assurance System establishment in organization & providing services for QA along with Regulatory Filings (DMFs / ANDA).
  • Contract Research Projects.


 



Product Development



 

CRAMS Product Development in case of APIs and Formulations are done in the below sequence of operations:-

  • Selection of molecule (information from client) followed by Literature Survey.
  • Selection of ROS followed by Technical and then Commercial Proposal.
  • Preparation of Protocol and approval from client.
  • Development of the product as per timelines meeting technical specifications.

 



Analytical Method

Analytical method development and analysis.

  • Compatibility Studies to be done (in case of formulations).
  • Stability Program Management and Analytical Method Validation.
  • Product Development Report and Product Transfer.